FDA Drug recall D-0689-2026
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Car…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Car… by Chiesi Usa, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0689-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-06 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Chiesi Usa |
| Distribution | US |
Product
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 10122-611-01 |
|---|---|
| ndc | 10122-611-10 |
| ndc | 10122-610-01 |
| ndc | 10122-610-10 |
| code_info | Lot #: 1239521, 1237454, Exp. Date 10/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0689-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.